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FDA nominee defends morning-after pill moves

The acting U.S. Food and Drug Administration chief sought support from senators for his stalled nomination on Tuesday, saying his plan to reconsider a "morning-after pill" was based on science and not politics.

Democrats questioned the FDA's announcement a day earlier that it might approve nonprescription sales of Barr Pharmaceuticals Inc.'s Plan B emergency contraceptive for women 18 and older. The set of two pills can prevent pregnancy when taken within 72 hours of sex.

The Plan B debate has lingered at the FDA for years, spawning charges that political pressure has overshadowed scientific evidence and holding up a previous nominee.

Dr. Andrew von Eschenbach said he had reviewed scientific data and felt Plan B could be used safely by that age group, but younger girls would need a doctor's guidance.

"No one told me what I should or could do. No one told me what decision I must or must not make. This was my assessment and my commitment, and I hope you'll judge me on that record," Von Eschenbach told the Senate Health, Education, Labor and Pensions Committee, which must approve his nomination before it can be considered by the full Senate.

Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington, both Democrats, have pledged to block von Eschenbach's nomination until the agency makes a final ruling on Plan B. An advisory panel recommended approval of over-the-counter sales, as did agency staff.

"Unfortunately, this is not just about Plan B," Clinton told von Eschenbach. "Once we start politicizing the FDA there is no stopping it; and from my perspective, it is essential that we draw the line. And we're drawing the line right here."

Von Eschenbach is an oncologist and cancer survivor who recently headed the National Cancer Institute. President George W. Bush named him acting FDA commissioner in September 2005 and in March nominated him for the post permanently.

Supporters say easier access to Plan B would help prevent abortions while opponents, mostly conservatives, argue it would spur promiscuity.

Other Democrats on the Senate panel asked why the FDA was now telling Barr nonprescription sales were only possible for women 18 and older. The company had originally applied for over-the-counter sales with no age restrictions and then revised its bid to 16 and older at the FDA's urging.

"It seems to me the line you are drawing is arbitrary," said Sen. Jack Reed (news, bio, voting record) of Rhode Island, another Democrat.

FDA approval of nonprescription sales is not certain. The agency told the company it must ensure that younger girls cannot obtain the product without a doctor's order.

Some Democrats voiced concern the FDA was placing Barr in an impossible position. "You're telling the manufacturer if they can't prove themselves that they can control the pharmacists across the country, all women will be denied access," Murray said.

Bush could bypass the Senate and appoint von Eschenbach while the Senate is in recess but has not threatened to do so.

The FDA's Plan B action upset some conservative groups that have fought against wider access. The Family Research Council said it would oppose von Eschenbach's nomination because of his willingness to consider approving Plan B, among other issues.